The following data is part of a premarket notification filed by Elekta Instrument Ab with the FDA for Leksell Gammaplan.
| Device ID | K173791 |
| 510k Number | K173791 |
| Device Name: | Leksell GammaPlan |
| Classification | System, Radiation Therapy, Radionuclide |
| Applicant | Elekta Instrument AB Kungstensgatan 18 Stockholm, SE 10393 |
| Contact | Matilda Forsberg |
| Correspondent | Matilda Forsberg Elekta Instrument AB Kungstensgatan 18 Stockholm, SE 10393 |
| Product Code | IWB |
| CFR Regulation Number | 892.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-14 |
| Decision Date | 2018-02-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07340048311236 | K173791 | 000 |
| 07340048311229 | K173791 | 000 |